GlaucomaIppocrateNCT06827535
Long-term Vascular, Functional and Morphological Changes in Glaucoma and Ocular Hypertensive Patients
An observational study of Glaucoma and Ocular Hypertension, run by Mario Stirpe at 5 sites in Italy.
Trial summary
This is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects. The aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- How many people
- 400 participants
- Where
- 5 sitesItaly
- Study dates
- 14 Nov 2024to 2 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People attending the hospital
Who may be able to join
- Diagnosis of primary glaucoma (open or closed angle) or secondary glaucoma (pseudoexfoliative or pigmentary) defined by the presence of a glaucomatous defect of the optic nerve and/or a perimetric glaucomatous defect as defined by the European guidelines
- Diagnosis of ocular hypertension (defined by the presence of intraocular pressure values≥22 mmHg, optic nerve and visual field examination within normal limits)
- No Optic nerve disease and IOP<21mmHg for healthy subjects
- Age>18 years
- Able to read and sing the informed consent form
Who cannot join
- BCVA <5/10
- Previous eye surgery, except glaucoma surgery or removal of cataracts performed more than 6 months prior to enrollment
- Other pathologies that can cause alterations of the optic nerve or visual field defects
- Presence of maculopathies
- Inability to perform visual field tests
- Opacity of the dioptric media such that it is not possible to perform reliable OCT and OCTA of acceptable quality
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites
Clinica Oculistica, DiNOGMI, Università di Genova
Genoa
Ospedale San Paolo - ASST Santi Paolo e Carlo
Milan, Italy, 20142
Ospedale Maggiore della Carità
Novara, Italy, 28100
Irccs-Fondazione Gb Bietti
Rome, Italy, 00184
Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmacologia Università di Sassari
Sassari, Italy, 07100
About this study
This is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects.
The aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal relationship of these changes.
Read the detailed description
This is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects.
The aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal relationship of these changes.
Secondary aims of the study are:
- evaluating the effect of age on functional, morphological and vascular changes and their relationship,
- evaluating the effect of myopia on functional, morphological and vascular changes and their relationship,
- evaluating clinical and demographic factors associated with glaucoma onset and progression,
- evaluating the effects of vascular, functional and morphological changes on quality of life
During the study patients will undergo BCVA assessment, biomicroscopy, IOP measurement, CCT measurement, gonioscopy, visual field test, optic nerve head and macula OCT scan, OCT angiography scan, fundoscopy, every 6 months (for glaucoma and ocular hypertensive patients) and every 12 months (for healthy subjects). The study lasts 3 years.
Four Italian glaucoma center will partecipate in this study, in addition to the promoter.
Four hundred patients and 100 healthy subjects will be involved.
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- glaucoma, ocular hypertension, vascular changes, morphological changes, functional changes
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma | iagnosis of primary glaucoma (open or closed angle) or secondary glaucoma (pseudoexfoliative or pigmentary) defined by the presence of a glaucomatous defect of the optic nerve and/or a perimetric glaucomatous defect as defined by European guidelines | |
| Ocular Hypertension | Diagnosis of ocular hypertension (defined by the presence of intraocular pressure values ≥22 mmHg, optic nerve and visual field examination within normal limits). | |
| Healthy subjects | No optic nerve disease IOP < 21 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of disease progression
Rate of progression of functional, morphological and vascular parameters, calculated on the basis of tests repeated over time
Measured: Up to 3 years
Secondary outcomes (4)
Rate of disease progression in relation to age
Rate of progression of functional, morphological and vascular parameters, in relation to age
Measured: Up to 3 years
Rate of disease progression in relation to myopia
Rate of progression of functional, morphological and vascular parameters, in relation to myopia
Measured: Up to 3 years
Rate of disease progression in relation to demographic data
Rate of progression of functional, morphological and vascular parameters, in relation to clinical and demographic factors collected at baseline (visual acuity, axial length, diagnosis, sex, stage of the disease, etc.)
Measured: Up to 3 years
Quality of life in glaucoma and ocular hypertensive patients
Quality of life questionnaire (National Eye Institute Visual Function Questionnaire-25) scores over time.
The minimum value is 0, the maximum value is 100. Higher score means a better outcome.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start14 Nov 2024
- Primary completion14 Nov 2028 (estimated)
- Study completion2 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Stirpe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mario Stirpe, Fondazione G.B. Bietti, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827535
- Sponsor's protocol ID
- GLC 04-24
- Acronym
- Ippocrate
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sotimehin AE, Ramulu PY. Measuring Disability in Glaucoma. J Glaucoma. 2018 Nov;27(11):939-949. doi: 10.1097/IJG.0000000000001068.
PubMed 30161076Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268.
PubMed 12365904
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Vascular, Functional and Morphological Changes in Glaucoma and Ocular Hypertensive Patients
- ClinicalTrials.gov ID
- NCT06827535
- Acronym / sponsor ID
- Ippocrate / GLC 04-24
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- glaucoma, ocular hypertension, vascular changes, morphological changes, functional changes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mario StirpeUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 14 Nov 2028 (estimated)
- Study completion
- 2 Jan 2030 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects.
The aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal relationship of these changes.
Detailed description
This is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects.
The aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal relationship of these changes.
Secondary aims of the study are:
- evaluating the effect of age on functional, morphological and vascular changes and their relationship,
- evaluating the effect of myopia on functional, morphological and vascular changes and their relationship,
- evaluating clinical and demographic factors associated with glaucoma onset and progression,
- evaluating the effects of vascular, functional and morphological changes on quality of life
During the study patients will undergo BCVA assessment, biomicroscopy, IOP measurement, CCT measurement, gonioscopy, visual field test, optic nerve head and macula OCT scan, OCT angiography scan, fundoscopy, every 6 months (for glaucoma and ocular hypertensive patients) and every 12 months (for healthy subjects). The study lasts 3 years.
Four Italian glaucoma center will partecipate in this study, in addition to the promoter.
Four hundred patients and 100 healthy subjects will be involved.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glaucoma | – | –iagnosis of primary glaucoma (open or closed angle) or secondary glaucoma (pseudoexfoliative or pigmentary) defined by the presence of a glaucomatous defect of the optic nerve and/or a perimetric glaucomatous defect as defined by European guidelines |
| Ocular Hypertension | – | –Diagnosis of ocular hypertension (defined by the presence of intraocular pressure values ≥22 mmHg, optic nerve and visual field examination within normal limits). |
| Healthy subjects | – | –No optic nerve disease IOP < 21 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People attending the hospital
Key inclusion criteria (5 listed)
- Diagnosis of primary glaucoma (open or closed angle) or secondary glaucoma (pseudoexfoliative or pigmentary) defined by the presence of a glaucomatous defect of the optic nerve and/or a perimetric glaucomatous defect as defined by the European guidelines
- Diagnosis of ocular hypertension (defined by the presence of intraocular pressure values≥22 mmHg, optic nerve and visual field examination within normal limits)
- No Optic nerve disease and IOP<21mmHg for healthy subjects
- Age>18 years
- Able to read and sing the informed consent form
Key exclusion criteria (6 listed)
- BCVA <5/10
- Previous eye surgery, except glaucoma surgery or removal of cataracts performed more than 6 months prior to enrollment
- Other pathologies that can cause alterations of the optic nerve or visual field defects
- Presence of maculopathies
- Inability to perform visual field tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of disease progression
Time frame: Up to 3 years
Rate of progression of functional, morphological and vascular parameters, calculated on the basis of tests repeated over time
4 secondary outcomes
Rate of disease progression in relation to age
Time frame: Up to 3 years
Rate of disease progression in relation to myopia
Time frame: Up to 3 years
Rate of disease progression in relation to demographic data
Time frame: Up to 3 years
Quality of life in glaucoma and ocular hypertensive patients
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Background: PubMed 30161076Sotimehin AE, Ramulu PY. Measuring Disability in Glaucoma. J Glaucoma. 2018 Nov;27(11):939-949. doi: 10.1097/IJG.0000000000001068.
- Background: PubMed 12365904Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Ocular Hypertension, run by Mario Stirpe at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of disease progression (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06827535, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.